In order to provide preliminary assessment of a drug's safety and efficacy, our preclinical CRO network in India offering both GLP-compliance regulatory toxicology studies for Investigational New Drug (IND) application and Non-GLP compliance toxicology studies. On the other way, our CMOs are GMP-compliant vendors offering CMC development including manufacturing process development, pre-formulation development, analytical method development & validation, clinical trial material manufacturing, packaging and stability studies required for the submission of an IND.
We can quantify drug levels in various body fluids and tissues even when they have been administered at very low dose levels. For high potency drugs, this means that we have the required sensitivity to enable preclinical research teams to administer ultra-low levels of their high potency drug and still obtain an accurate result.